Prognostic Relevance of Biological Subtype in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Prognostic Relevance of Biological Subtype Overrides That of TNM Staging in Breast Cancer: Discordance Between Stage and Biology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02063906
• Other study ID #: 2014-02-045
• Status: Recruiting
• Phase: N/A
• First received: February 12, 2014
• Last updated: April 27, 2017
• Start date: February 2014
• Est. completion date: May 2019

Study information

• Verified date: April 2017
• Source: Samsung Medical Center
• Contact: Young-Hyuck Im, MD, PhD
• Email: yh00.im[@]samsung.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Recently, the investigators face "on the edges" for treatment decision to decide adjuvant systemic treatment, especially for patients who show discordance between stage and tumor biology. The aim of this study was to compare the prognostic relevance of the TNM staging system and intrinsic subtype in breast cancer patients who received curative surgery.

Description:

Identified patients who received curative surgery for stage I-III breast cancer and had available data on immunohistochemistry profiles including hormone receptor status (HR) status, human epidermal growth factor receptor 2 (HER2) status, and Ki 67 staining at Samsung Medical Center from January 2004 to September 2008. Primary outcomes were recurrence-free survival (RFS) and overall survival (OS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: May 2019
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients who received curative surgery

• stage I-III breast cancer

• between January 2004 and September 2008

• had available immunohistochemistry profiles.

exclusion Criteria:

• age <18 years old

• microinvasive carcinoma of breast

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center, Sungkyunkwan University School of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	was measured from the first date of diagnosis of breast cancer to the date of death or the last follow-up visit	1 year
Secondary	Recurrence-free survival	was defined as the time from the date of curative resection to the date when breast cancer recurred, irrespective of locoregional recurrences including ipsilateral and contralateral breast recurrences or distant metastases.	1 Year